Cortexyme’s COR388 GAIN Trial Advances to Endpoint; Results Expected Late 2021

Cortexyme’s COR388 GAIN Trial Advances to Endpoint; Results Expected Late 2021
Cortexyme’s ongoing Phase 2/3 GAIN clinical trial, which is evaluating the investigational treatment COR388 (atuzaginstat) in people with mild to moderate Alzheimer’s disease, has been approved to continue as planned to its one-year endpoint, the company said. Topline results from the study, testing whether COR388 can lessen dementia and neurodegeneration in Alzheimer's, are expected on time in December 2021. The trial recommendation was given by the independent Data Monitoring Committee (DMC) — a panel of independent scientists who monitor trial conduct and safety — after a pre-planned interim analysis of data that included about 300 patients who have received treatment for six months. The DMC assessed criteria including safety, primary outcome efficacy, whether the number of participants is sufficient, and the overall likelihood the therapy will produce significant benefits (futility). The company remains blinded to the results. “Given the tremendous unmet need in Alzheimer’s disease, it is imperative that we rapidly and efficiently study potential new treatments,” Marwan Sabbagh, MD, director of the Cleveland Clinic Center for Brain Health and GAIN's principal investigator, said in a press release. “We look forward to completing the study and sharing the results with the medical community and patients when the full trial results become available,” Sabbagh said. Michael Detke, MD, PhD, Cortexyme’s chief medical officer, said the company was pleased with the DMC recommendation, "which we believe supports the study design and statistical powering of the GAIN Trial.”  GAIN (NCT03823404), which now has enrolled 643 participants ages 55 to 80, is a randomized, placebo-controlled study evaluating 40 and 80 mg of COR388, or a pla
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